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• W2013674461 abstract "Synopsis: Dalcetrapib will be prescribed to increase high-density lipoprotein cholesterol by reducing cholesteryl ester transfer protein activity, and potentially reduce residual cardiovascular risk. Patients administered dalcetrapib will most likely include women co-prescribed an oral contraceptive (OC). We investigated the potential for drug-drug-interaction in women co-administered dalcetrapib 900 mg once daily ([QD] a supratherapeutic dose greater than 600 mg tested in phase 3 trials) and Microgynon-30 QD, a widely prescribed monophasic OC. Purpose: Assess the effect of dalcetrapib on the pharmacokinetics of Microgynon-30, which comprises ethinyl estradiol ([EE] 0.03 mg) and levonorgestrel ([LN] 0.15 mg). Effect on ovulation suppression by Microgynon-30, and dalcetrapib safety and tolerability were also assessed. Methods: A single-center, open-label, randomized, 2-way crossover study in healthy women (aged 18–40 years and body mass index 18–30 kg/m2) receiving a monophasic OC containing ≥0.03 mg EE for ≥3 months. Subjects received Microgynon-30 QD for 21 days followed by 7 treatment-free days (run-in period), followed by Microgynon-30 QD for 21 days (days 1–21) with or without dalcetrapib 600 mg QD for 14 days (days 1–14). Plasma concentrations of EE and LN were measured on day 14. Concentrations of luteinizing hormone, follicle stimulating hormone, progesterone and estrogen were measured at intervals. Primary pharmacokinetic variables evaluated for EE and LN were total (AUC0-24) and peak (Cmax) exposure on day 14. Statistical comparisons were made between treatments for EE and LN exposure parameters AUC0-24 and Cmax on day 14. The geometric mean ratio was calculated for both parameters for Microgynon-30 co-administered with dalcetrapib relative to Microgynon-30 alone. Safety was monitored throughout. Results: Thirty subjects were randomized, of whom 28 completed both treatments. Measures of EE and LN exposure were each similar when Microgynon-30 was given alone or in combination with dalcetrapib; 90% confidence intervals for GMR comparisons of total and peak exposure were all within the accepted equivalence limits of 0.8 to 1.25. Concentrations of LH and FSH on day 14 were comparable between treatments. Overall, dalcetrapib was well tolerated. Although the number of subjects reporting AEs was higher during coadministration of dalcetrapib with Microgynon-30 (86%) than during administration of Microgynon-30 alone (60%), most AEs were mild and the profile of events was similar between treatments. Conclusions: Dalcetrapib has no clinically relevant effect on the pharmacokinetics of EE and LN. Contraceptive efficacy of Microgynon-30 is not anticipated to be compromised by coadministration of dalcetrapib." @default.
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• W2013674461 date "2010-05-01" @default.
• W2013674461 modified "2023-09-25" @default.
• W2013674461 title "No Clinically Relevant Drug-Drug Interactions Between Dalcetrapib and a Monophasic Oral Contraceptive (Microgynon-30®)" @default.
• W2013674461 doi "https://doi.org/10.1016/j.jacl.2010.03.045" @default.
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